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WASHINGTON — The Food and Drug Administration is requiring the manufacturers of popular sleep drugs that contain the active ingredient zolpidem to lower current recommended doses.
The FDA said Thursday that new data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that need alertness, such as driving.
Zolpidem medications cited by the agency included Ambien and Ambien CR (sanofi-aventis), Edluar (Meda Pharmaceuticals) and Zolpimist (ECR Pharmaceuticals), as well as generic versions of Ambien and Ambien CR.
Manufacturers have been informed by the FDA that the recommended dosage of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing doses of 5 mg for immediate-release products and 6.25 mg for extended-release products.
The products are currently available on the market in both the higher and lower dosages.
Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours. Women eliminate zolpidem from their bodies more slowly than men, and the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs, the FDA reported.
"To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia," stated Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. "Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate."
According to Unger, the FDA over the years has received adverse event reports of driving impairment and motor vehicle accidents related to zolpidem. "But these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive," he explained. "Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment."
The FDA added that it’s continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter medicines.
